FDA Adverse Event Malfunction Summary report: N

IVT DISPOSABLE

MDR report key: 2252272 · Received September 16, 2011

Report

Report Number: 6000001-2011-25354
Event Type: Malfunction
Date Received: September 16, 2011
Date of Event: August 1, 2011
Report Date: August 24, 2011
Manufacturer: BAXTER HEALTHCARE - MALTA
Product Code: KPE
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: UK
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT CONTAIN A US 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US. A SAMPLE IS NOT AVAILABLE FOR EVALUATION; THEREFORE, THE CONDITION CANNOT BE CONFIRMED OR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative · 1

(B)(4). THE SAMPLE IS NOT AVAILABLE FOR EVALUATION, THEREFORE, THE CONDITION CANNOT BE CONFIRMED OR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED. HOWEVER, A BATCH REVIEW WAS PERFORMED ON THE REPORTED LOT AND NO DEVIATIONS WERE NOTED.

Description of Event or Problem · 1

A CUSTOMER REPORTED TO BAXTER (B)(4) OF A 500ML EVA BAG IN WHICH DURING FILLING, THERE WERE PARTICLES IN THE BAG. THERE WAS NO PATIENT INVOLVEMENT, INJURY OR MEDICAL INTERVENTION NECESSARY IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 69 OF 108.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	IVT DISPOSABLE	CONTAINER, I.V.	KPE	BAXTER HEALTHCARE - MALTA		11B01V522M

Patients

Seq	Age	Sex	Outcome	Treatment
1